Monitoring of the Lenalidomide Pregnancy Prevention Programme (PPP) Implementation and Effectiveness in Europe (Lena-PIE Europe)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/49558
• EU PAS number:
  EUPAS49520
• Study ID:
  49558
• Official title and acronym:
  Monitoring of the Lenalidomide Pregnancy Prevention Programme (PPP) Implementation and Effectiveness in Europe (Lena-PIE Europe)
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  Evaluation of the outcome indicator (safety outcome): (i) Systematic database review in STADA’s safety database to ensure that no pregnancy case in association with an exposition to a lenalidomide product of the STADA group included in the concerned procedures was missed. Initiation of follow-up and root-cause analysis of missed cases. (ii) Systematic review of EudraVigilance data to identify pregnancy cases in association with an exposition to a lenalidomide product of the STADA group included in the concerned procedures not known to STADA. Initiation of data entry and processing in STADA’s safety database as well as initiation of follow-up and root-cause analysis of cases not known.
• Study status:
  Ongoing

Research institutions and networks

Institutions

STADA Arzneimittel

Study timelines

Date when funding contract was signed

Planned: 05/10/2022

Actual: 05/10/2022

Study start date

Planned: 27/10/2022

Actual: 27/10/2022

Data analysis start date

Planned: 27/10/2027

Date of final study report

Planned: 27/10/2028

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

STADA Arzneimittel AG

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)

Other study registration identification numbers and links

STADA study code: PASS-37480-22-0250